Stress Urinary Incontinence in WomenMiniArcNCT00541151
MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
An observational study of Stress Urinary Incontinence in Women, run by American Medical Systems at 1 site in United States.
Trial summary
Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence in Women
- What is being tested?
- MiniArc
- Type of treatment
- Medical device
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females 18 years or older who have confirmed SUI
Who may be able to join
- Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise.
Who cannot join
- Unwilling or unable to sign ICF
- Unable to understand the study or has a history of non-compliance with medical devices
- Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses
- Pelvic prolapse greater than grade 3
- Is, in the investigator's opinion, otherwise unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
McKay Urology Research
Charlotte, North Carolina, 28207
About this study
Official title: Long-Term Effectiveness Trial for AMS Sling Systems
Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.
Read the detailed description
This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.
- Conditions
- Stress Urinary Incontinence in Women
- Being tested
- MiniArc
- Keywords
- Stress urinary incontinence in Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniArcDevice
Also called MiniArc or single incision sling
sling system
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use.
Measured: 2 years
Secondary outcomes (1)
Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence in WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Kennelly, MD, Principal investigator, McKay Urology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541151
- Sponsor's protocol ID
- WC0605
- Acronym
- MiniArc
- Status last verified
- Aug 2010
- First submitted
- 5 Oct 2007
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effectiveness Trial for AMS Sling Systems
- ClinicalTrials.gov ID
- NCT00541151
- Acronym / sponsor ID
- MiniArc / WC0605
- Conditions
- Stress Urinary Incontinence in Women
- Keywords
- Stress urinary incontinence in Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- American Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.
Detailed description
This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females 18 years or older who have confirmed SUI
Key inclusion criteria (1 listed)
- Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise.
Key exclusion criteria (5 listed)
- Unwilling or unable to sign ICF
- Unable to understand the study or has a history of non-compliance with medical devices
- Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses
- Pelvic prolapse greater than grade 3
- Is, in the investigator's opinion, otherwise unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniArcAlso: MiniArc or single incision slingsling system | Device | – |
Primary outcome
Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use.
Time frame: 2 years
1 secondary outcome
Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kennelly, MD principal investigator
McKay Urology Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence in Women, run by American Medical Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.